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Trial record 27 of 168 for:    MPL

Study to Evaluate the Leish-111F + MPL-SE Vaccine in the Treatment of Cutaneous Leishmaniasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00111553
Recruitment Status : Completed
First Posted : May 24, 2005
Last Update Posted : February 15, 2007
Bill and Melinda Gates Foundation
Information provided by:

Brief Summary:
This study will evaluate the safety of the Leish-111f + MPL-SE vaccine in adult patients with cutaneous leishmaniasis.

Condition or disease Intervention/treatment Phase
Leishmaniasis, Cutaneous Biological: Leish-111f + MPL-SE vaccine Phase 1

Detailed Description:

Cutaneous leishmaniasis is a disfiguring infection that can progress to mucosal leishmaniasis, a more serious and possibly fatal form of leishmania infection. All available medical therapies require weeks of treatment and cause significant toxicity. In Brazil, a standard therapy is Glucantime treatment, administered in cycles of 10 consecutive, once daily, intramuscular injections (Glucantime 10 mg/kg, maximum of 850 mg), followed by 11 consecutive days without Glucantime injections (rest days). At the completion of each cycle, a study physician examines the patient to determine if a further cycle of Glucantime treatment is indicated.

It appears that Leishmania infections can be eliminated by T helper 1 immune responses. This finding argues that a vaccine that augments cutaneous leishmaniasis patients' T helper 1 response will eliminate the infection and disease. This study is a phase 1, randomized, double-blind, placebo controlled, sequential dose-escalating trial to evaluate the safety and immunogenicity of three injections of 5, 10, or 20 μg of Leish-111f protein + 25 μg of MPL-SE adjuvant given at 4 week intervals as an adjunct to the standard chemotherapy with Glucantime cycles, as described above in patients with cutaneous leishmaniasis.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Randomized, Double-Blind, Adjuvant- and Placebo-Controlled, Dose-Escalating Study to Evaluate Safety, Tolerability, and Immunogenicity of Leish-111f + MPL-SE Vaccine With Meglumine Antimoniate (Glucantime) in Cutaneous Leishmaniasis
Study Start Date : October 2004
Study Completion Date : August 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leishmaniasis

Primary Outcome Measures :
  1. Occurrence of dose limiting toxicity
  2. Adverse events

Secondary Outcome Measures :
  1. IgG and T-cell response to Leish-111f vaccine
  2. Leish-111f skin test reactivity
  3. Safety of the vaccine with respect to the clinical course of cutaneous leishmaniasis

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Confirmed diagnosis of cutaneous leishmaniasis defined as positive identification of parasite from lesion biopsy
  • Normal lab values and electrocardiogram (ECG)
  • Negative for HIV, hepatitis B and C, and Chagas disease

Exclusion Criteria:

  • Nine or more active cutaneous lesions
  • Lesion diameter >60mm
  • Previous exposure to Leishmania vaccines or to MPL-SE
  • Pregnant or breastfeeding female

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00111553

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Universidade Federal de Minas Gerais
Belo Horizonte, Minas Gerais, Brazil, 31270-901
Ambulatório de Leishmanioses da Secretaria Municipal da Saude de Januária
Januária, Minas Gerais, Brazil, 39480-000
Sponsors and Collaborators
Bill and Melinda Gates Foundation
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Principal Investigator: Evaldo Nascimento, MD Federal University of Minas Gerais
Study Director: Franco M Piazza, MD, MPH Infectious Disease Research Institute (IDRI)
Layout table for additonal information Identifier: NCT00111553    
Other Study ID Numbers: IDRI-LCVTC-101
First Posted: May 24, 2005    Key Record Dates
Last Update Posted: February 15, 2007
Last Verified: February 2007
Keywords provided by IDRI:
Subunit vaccine
T cell
Additional relevant MeSH terms:
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Leishmaniasis, Cutaneous
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases